pramipexole
Last reviewed 2025-12-30
Reviewed by PsychMed Editorial Team.
Brands: Mirapex
Sources updated 2025 • 4 references
General Information
Pramipexole (brand Mirapex) is a non-ergoline dopamine agonist indicated for Parkinson’s disease and moderate-to-severe primary RLS (label).
In RLS, dopamine agonists can improve symptoms but require long-term risk management. A key concern is augmentation, which shapes follow-up plans and influences drug selection frameworks (guideline/clinical).
Clinically important adverse effects include somnolence/sudden sleep onset, orthostatic hypotension, hallucinations/psychosis, and impulse-control symptoms; these risks can be especially relevant in serious mental illness (label/clinical).
Pramipexole is largely renally eliminated as unchanged drug; dosing and tolerability are tied to kidney function and require adjustment in renal impairment (label).
The pramipexole compare view, evidence feed, and print page support side-by-side review of RLS options and monitoring topics.
U.S. approvals
- Parkinson’s disease (PD) ()
- Moderate-to-severe primary restless legs syndrome (RLS) ()
Formulations & strengths
- Tablets: 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 1.5 mg (label).
Generic availability
- Widely available generically.
In RLS, pramipexole is usually positioned with explicit monitoring for augmentation and neuropsychiatric adverse effects. In patients with mood or psychotic disorders, dopaminergic activation risks can be clinically limiting and may shift preference toward non-dopaminergic strategies (guideline/clinical).
View labelExactMechanism of Action
Refer to the Glossary entry on Neurotransmitters for background on receptor systems involved in serious mental illness.
Dopamine agonist with high relative affinity for D2/D3 receptor subtypes (label/class).
Clinical effects in PD reflect dopaminergic stimulation; in RLS, dopaminergic system involvement is a common mechanistic frame (label/class).
Dopaminergic therapies can precipitate or worsen hallucinations, impulsivity, and mood destabilization in vulnerable patients, which is relevant in serious mental illness (label/clinical).
- Dopamine receptor agonism (D2/D3 preference; class-level).
Metabolism and Pharmacokinetics
- Pramipexole is rapidly absorbed with high oral bioavailability and is metabolized only to a negligible extent (<10%) (label).
- Urinary excretion is the major route of elimination; ~90% of a dose is recovered in urine, almost all as unchanged drug (label).
- Terminal half-life is ~8 hours in younger adults and ~12 hours in older adults; steady state is typically achieved within ~2 days (label).
Dosing and Administration
- RLS: start 0.125 mg once daily 2 to 3 hours before bedtime; dose may be increased every 4 to 7 days based on response and tolerability (label).
- For RLS, there is no evidence that 0.75 mg provides additional benefit beyond 0.5 mg (label).
- Renal impairment requires dose adjustment; dose selection is based on creatinine clearance (label).
- Parkinson’s disease uses different titration schedules and higher total daily doses than RLS; indication-specific dosing is important (label).
Monitoring & Labs
- Somnolence and sudden sleep onset monitoring; driving safety review (label).
- Orthostatic blood pressure and dizziness/falls risk monitoring (label/clinical).
- Hallucinations/psychosis and mood destabilization monitoring, especially in serious mental illness (label/clinical).
- Impulse-control symptom monitoring (new compulsive behaviors) (label/clinical).
- RLS symptom timing tracking to detect augmentation (earlier onset, increased severity, spread) (guideline/clinical).
- Renal function review and renal-dose adjustment as needed (label).
Adverse Effects
FDA boxed warnings
Common side effects (≥10%)
- Nausea: Common and dose-related; titration speed affects tolerability (label/clinical).
- Somnolence / sudden sleep onset: Can be safety-critical; assess next-day impairment and driving risk (label).
- Dizziness / orthostatic hypotension: More common during titration and in older adults; monitor falls risk (label/clinical).
Other notable effects
- Hallucinations, confusion, and psychotic symptoms can occur and may be more likely in older adults or those with baseline psychiatric vulnerability (label/clinical).
- Impulse-control symptoms (e.g., compulsive behaviors) have been reported with dopamine agonists; monitoring for behavioral change is clinically important (label/clinical).
- In RLS, long-term use can be complicated by augmentation and rebound, which may present as earlier onset or worsening severity (guideline/clinical).
Interactions
- Pramipexole has negligible CYP metabolism; CYP-based interactions are limited (label).
- Cimetidine and other inhibitors of renal tubular secretion can increase exposure and half-life; monitoring for increased adverse effects is commonly considered when these are started or stopped (label).
- Additive sedation can occur with alcohol and other CNS depressants (label/clinical).
Other Useful Information
- RLS care frameworks emphasize screening for contributors (iron deficiency, sleep apnea, medication triggers) and reassessing treatment when symptoms shift earlier in the day or intensify (guideline/clinical).
- AASM guidance and updated algorithms highlight augmentation monitoring and support use of non-dopaminergic options when augmentation risk or psychiatric vulnerability is high (guideline).
References
- Pramipexole dihydrochloride tablets prescribing information — DailyMed (2025)
- Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine clinical practice guideline — Journal of Clinical Sleep Medicine (2025)
- The Management of Restless Legs Syndrome: An Updated Algorithm — Mayo Clinic Proceedings (2021)
- Randomized Trial OF Pramipexole FOR Patients With Restless Legs Syndrome (rls) AND RLS Related Impairment OF Mood — Sleep Medicine (2011)